In Korea, the Ministry of Food and Drug Safety (MFDS) is in charge of regulating pharmaceutical products and services.
Pharmaceutical companies submit a Fosrenol Drug Master File in Korea (Fosrenol KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Fosrenol. The MFDS reviews the Fosrenol KDMF as part of the drug registration process and uses the information provided in the Fosrenol KDMF to evaluate the safety and efficacy of the drug.
After submitting a Fosrenol KDMF to the MFDS, the registered manufacturer can provide importers or distributors with the registration number without revealing confidential information to Korean business partners. Applicants seeking to register their Fosrenol API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Fosrenol suppliers with KDMF on PharmaCompass.